Associate Medical Director, Clinical Research, Cardiovascular
Cytokinetics
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $232,200 - $270,900 per year
Job Level
About the role
- Serves as a source of medical expertise for clinical project teams
- Provides input to decisions that have medical, scientific, and future marketing implications
- Provides medical input into the design, planning, initiation and completion of clinical trials
- Responsible for the preparation of the medical components of study protocols and IND and other regulatory submissions
- Serves as the medical monitor for the successful conduct, integrity, and safety of patients in our clinical trials
- Partner with Research, Regulatory Affairs, Medical Affairs, Biometrics, Clinical Operations, Safety, Quality Assurance, Product Development, Business Development, and Management to formulate and implement comprehensive clinical trial plans
- Establishes communications and relationships with prominent clinical investigators in the area of cardiovascular disease
- Attends appropriate scientific meetings to maintain awareness of research activities and represents a project and/or Company at such external events
- Applies the strategic intent of the Company when working with regulatory bodies such as FDA, and with key opinion leaders
- Performs product safety medical reviews for assigned investigational drugs
- Ensures an appropriate level of customer service to internal and external customers
Requirements
- MD, MD/PhD, or DO degree with cardiology board certification by the American Board of Internal Medicine
- Significant clinical investigator experience or a minimum of 2 years in clinical development experience in a biotechnology or pharmaceutical company
- Sub-specialty training is required
- Industry experience in the clinical development of cardiovascular therapeutics and experience with studies in heart failure is a strong plus
- Knowledge of CDER regulations/ICH
- Understanding of pharmaceutical safety reporting and surveillance requirements
- Excellent verbal and written communication skills and presentation skills
- Strong interpersonal skills
- Leadership skills
- Desire to work within a multidisciplinary team
- Computer literacy
- Ability to work internationally
Benefits
- Health insurance
- Flexible working arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial designmedical monitoringproduct safety medical reviewsregulatory submissionsclinical developmentcardiovascular therapeuticspharmaceutical safety reportingICH regulationsCDER regulationsinvestigational drug experience
Soft skills
verbal communicationwritten communicationpresentation skillsinterpersonal skillsleadership skillsteam collaborationcustomer servicerelationship buildingstrategic thinkingmultidisciplinary teamwork
Certifications
MDMD/PhDDOcardiology board certification